Alexza Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency (EMA) for its Adasuve Staccato loxapine for adult patients with schizophrenia or with bipolar disorder. Grupo Ferrer will market Adasuve in Europe if the EMA approves the application. In the US, the company resubmitted an NDA for the product in August 2011 after receiving a complete response letter for its original submission.
Alexza Senior Vice President, Research and Development James Cassella anticipates that the process will be smoother in Europe: “During the last six months, we have conducted pre-submission meetings with both our Rapporteur and Co-Rapporteur, and we believe we have a good understanding of their expectations for our Adasuve MAA submission. Our submission has been developed to address their inputs and feedback, and we are very excited to have the European review process initiated. In addition to information from the US NDA, our Adasuve MAA submission contains additional analysis of the primary efficacy data, and a comprehensive comparison of Staccato loxapine and other injectable drugs used to treat agitation.”
Alexza President and CEO Thomas King added, “Our MAA submission is another important step in the development of Adasuve. We are optimistic that we will receive timely European review, as we begin to work with our partner Grupo Ferrer, in executing our European commercialization strategy. We believe Adasuve offers an innovative therapeutic option for the treatment of agitation associated with schizophrenia or bipolar disorder.”
Read the Alexza press release.
